The purpose of this study is to assess clinical response and patient satisfaction when DFD-01 is used topically twice a day for moderate plaque psoriasis.
This multicenter, multi-dose, open-label study was designed to assess clinical response and patient-reported satisfaction after dosing with DFD-01 twice daily for 28 days. The product was approved for the treatment of mild to moderate plaque psoriasis by the FDA on February 5, 2016 before the first patient was enrolled. Forty five (45) adult males and females, 18 years of age and older with a clinical diagnosis of moderate plaque psoriasis who met inclusion/exclusion criteria were randomized at the Baseline Visit. Each site attempted to enroll 50% of the patients with 3% to 10% body surface area (BSA) involved and 50% of the patients with \> 10% BSA involved. The initial dose of study product was self-administered by the patient and supervised by clinic staff during the Baseline Visit. Patients continued to apply the study product to all affected areas (avoiding the face, scalp, groin, axillae or other intertriginous areas) twice daily (approximately 12 hours apart) for 28 days. Patients visited the clinic for a total of up to five scheduled visits: * Screening (Day -60 to 1)\* * Baseline (Day 1) * Interim Visit (Day 8 ± 2) * Interim Visit (Day 14 ± 3) * End of Study (Day 29 ± 3)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
Site Four
Arlington Heights, Illinois, United States
Site Two
New Albany, Indiana, United States
Site One
Louisville, Kentucky, United States
Site Three
Las Vegas, Nevada, United States
Change in Investigator's Global Assessment Grade
The mean change in the IGA score from baseline to Day 14 was assessed. IGA score is a static assessment of disease severity and is based on overall severity of signs at each visit. It's a 4-point scale where '0' is absent disease and '4' is 'Severe/Very Severe' disease. A lower score at the end of the study compared to baseline (negative change), indicates an improvement in the disease condition.
Time frame: Change from Baseline to Day 14.
Change in Percent Body Surface Area (BSA) Involved.
Change in the BSA of involvement with psoriasis from baseline to Day 14 was assessed. BSA was assessed at Baseline, Days 8, 14 and 29.
Time frame: Change from Baseline to Day 14.
Change in Dermatology Life Quality Index (DLQI)
DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (i.e., negative change score) indicates improvement in the Quality of Life.
Time frame: Change from Baseline to Day 14.
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